Packaging and storage—
Preserve in tight containers, and store at controlled room temperature.
Identification—
B:
The RF value of the principal spot observed in the chromatogram of the test solution corresponds to that of the principal spot observed in the chromatogram of the Standard solution, as obtained in the test for Chromatographic purity.
Chromatographic purity—
Dissolve 50 mg of it in 3.0 mL of glacial acetic acid in a 5-mL volumetric flask, dilute with glacial acetic acid to volume, and mix. Similarly prepare a Standard solution containing 5 mg of
USP Albendazole RS per mL. Transfer 1.0 mL of the Standard solution to a 100-mL volumetric flask, dilute with glacial acetic acid to volume, and mix (diluted Standard solution). Apply 10-µL portions of the test solution, the Standard solution, and the diluted Standard solution to a suitable thin-layer chromatographic plate (see
Chromatography 
621
), coated with a 0.25-mm layer of silica gel mixture, and allow the spots to dry. Develop the chromatogram in a solvent system consisting of a mixture of chloroform, glacial acetic acid, and ether (60:10:10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, allow the solvent to evaporate from the plate, and examine the plate under short-wavelength UV light: no spot, other than the principal spot, in the chromatogram of the test solution is larger or more intense than the principal spot in the chromatogram of the diluted Standard solution (0.5%).
Assay—
Transfer about 250 mg of Albendazole, accurately weighed, to a suitable flask, and dissolve in 100 mL of glacial acetic acid, warming gently if necessary. Cool, add 1 drop of
oracet blue B TS, and titrate with 0.1 N perchloric acid VS to a violet-colored endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 26.53 mg of C
12H
15N
3O
2S.
Auxiliary Information—
Staff Liaison :
Ian DeVeau, Ph.D., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 60
Pharmacopeial Forum : Volume No. 27(3) Page 2505
Phone Number : 1-301-816-8178
;)
for 4 hours: it loses not more than 0.5% of its weight.